<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2014021516578N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-28</date_registration>
      <primary_sponsor>Bala Murali Sundram</primary_sponsor>
      <public_title>Effects of Progressive Muscle Relaxation as part of a Worksite Health Promotion Program to Alleviate Stress in the Automotive Assembly Line.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Progressive Muscle Relaxation as part of a Worksite Health Promotion Program to Alleviate Stress in the Automotive Assembly Line: A Quasi Experimental Study.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>176</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>occupational stress.</hc_freetext>
      <i_freetext>Intervention 1: Plant B as the pamphlet group acting as control. Intervention 2: The study was conducted in the state of Selangor, Malaysia at a place called Rawang, from the district of Hulu Selangor. Plant A was selected as the intervention group for the combined Progressive Muscle Relaxation (PMR) therapy .The study in both groups commenced in January 2012 and assessed with the shortened and self-administered Depression, Anxiety and Stress Scale (DASS-21) questionnaire. The reinforcement sessions were done from baseline at 2 monthly intervals till 9th month in the PMR group. The control group received pamphlet distribution on stress, at baseline and end of 9th month. The sample for the study were voluntary individuals willing to participate, taken from the study population whom were screened by the short, self-administered and validated Malay version of Depression, Anxiety and Stress Scale (DASS-21) questionnaire.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bala Murali Sundram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip>50603</zip>
        <telephone>00637967 4928</telephone>
        <email>balamurali@siswa.um.edu.my</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maznah Dahlui</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip></zip>
        <telephone>00637967 4756</telephone>
        <email>maznahd@um.edu.my</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were all male workers directly attached to the production line and who had been working at the site for more than 1 year. &#13;
Respondents with psychiatric illnesses with or without medication, having prior training or current use of relaxation therapy, working less than 1 year and respondents without consent were excluded.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Plant B as the pamphlet group acting as control.</i_keyword>
      <i_keyword>The study was conducted in the state of Selangor, Malaysia at a place called Rawang, from the district of Hulu Selangor. Plant A was selected as the intervention group for the combined Progressive Muscle Relaxation (PMR) therapy .The study in both groups commenced in January 2012 and assessed with the shortened and self-administered Depression, Anxiety and Stress Scale (DASS-21) questionnaire. The reinforcement sessions were done from baseline at 2 monthly intervals till 9th month in the PMR group. The control group received pamphlet distribution on stress, at baseline and end of 9th month. The sample for the study were voluntary individuals willing to participate, taken from the study population whom were screened by the short, self-administered and validated Malay version of Depression, Anxiety and Stress Scale (DASS-21) questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 2 monthly interval for 9 months from baseline. Method of measurement: Depression,Anxiety, Stress Scale (DASS-21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>U1111-1153-4963</sec_id>
        <issuing_authority>WHO Universal Trial Number(UTN)</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bala Murali Sundram</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-18</approval_date>
        <contact_name>Medical Ethics Committee, University Malaya Medical Centre</contact_name>
        <contact_address>Lembah Pantai, Kuala Lumpur Kuala Lumpur Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
